MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE NAV; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number	0036368159
Medical Device Problem Codes	Nonstandard Device (1420); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	10/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the patient experienced a pericardial effusion.During a pulse field ablation (pfa) procedure to treat paroxysmal atrial fibrillation a farawave nav catheter was used.Access was gained without issue.A pre-effusion check was performed with intracardiac echocardiography (ice) which showed a small effusion which the physician noted.The transseptal puncture was performed with the stick appearing to be pointing at the ridge posterior to the left atrial appendage (laa) and mid-level on the septum.There was some difficulty getting the sheath across the septum and placing the coronary sinus catheter.The difficulty was attributed to the nature of the patient's septum being fairly fibrotic.The catheter was inserted and used for mapping and ablation workflow.The left veins were isolated with no apparent issues.Multiple unsuccessful attempts were made to wire the right inferior pulmonary vein (ripv) and deliver ablations in the basket shape.It was noticed that resistance was felt maneuvering the guidewire, specifically in the ripv.Some bunching errors (error 301 pre-pulse failure and 303 arc detect failure) were noted along with a lack of coaxial placement, so ablations were made in the flower shape around the ripv.Some visible spline bunching was also observed on fluoroscopy.Afterwards some deliveries in the basket shape were able to be made successfully before moving the catheter to the right superior pulmonary vein (rspv).Two basket ablations were made without issue before the patient's lines were checked.Another effusion check was performed as well which revealed a sizable effusion.Pericardiocentesis was performed and the patient was sent to the intensive care unit (icu).The procedure had to be cancelled due to the complication, but the patient fully recovered.The device is not expected to be returned for analysis due to disposal.

• Brand Name: FARAWAVE NAV
• Common Device Name: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23606581
• Report Number: 2124215-2025-84982
• Device Sequence Number: 13223722
• Product Code: QZI
• UDI-Device Identifier: 00191506043209
• UDI-Public: (01)00191506043209(17)260424(10)36368159
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2026
• Device Lot Number: 0036368159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 04/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown